A Phase 2 Platform Study to Evaluate Therapies for Inflammatory Bowel Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Mirador Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

27 May 2026 → ongoing

Decision date (initial)

2025-10-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Mirador Therapeutics Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Safety, Pharmacokinetic

Evaluate safety and tolerability following Induction Phase (IP);
Prospective Observer-Blinded Endpoint ISAs: Assess the proportion of participants with endoscopic response (CD) or endoscopic improvement (UC) at end of IP;
Randomized Placebo-Controlled ISAs: Assess the proportion of participants with clinical remission at end of IP.

Secondary objectives 11

1. Prospective Observer-Blinded Endpoint ISAs: Assess the proportion of participants with clinical remission at end of IP
2. Randomized Placebo-Controlled ISAs: Assess the proportion of participants with endoscopic response (CD) or endoscopic improvement (UC) at end of IP
3. Assess the proportion of participants with symptomatic remission at end of IP
4. Assess the proportion of participants with clinical response at end of IP
5. Assess the proportion of participants with endoscopic and clinical response at end of IP (CD only)
6. Assess proportion of participants with histologic response at end of IP (UC only)
7. Assess proportion of participants with histologic remission at end of IP (UC only)
8. Assess proportion of participants with histologic-endoscopic mucosal improvement at end of IP (UC only)
9. Characterize the change in endoscopy score from Day 1 to end of IP
10. Characterize the change in histology score from Day 1 to end of IP
11. Assess the pharmacokinetics (PK) of investigational drug

Conditions and MedDRA coding

Crohn’s Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. ≥ 18 to ≤ 80 years old.
2. Able to provide written informed consent and understand and comply with the requirements of the study specified both in the Master Protocol and the ISA.
3. Participants must have had insufficient response and/or intolerance to corticosteroid, immunosuppressants, and/or an approved advanced therapy for UC or CD.
4. Female participants must be of non-childbearing potential or have a negative serum pregnancy test at time of Screening if of childbearing potential. Additional requirements for birth control methods apply for each ISA.
5. CD: Documented diagnosis of CD.
6. CD: Moderately to severely active CD as defined by CDAI.
7. CD: SES-CD (per central reading) consistent with moderate to severely active CD.
8. CD: Participants must meet drug stabilization requirements.
9. UC: Documented diagnosis of UC.
10. UC: Moderately to severely active UC.
11. UC: Participants must meet drug stabilization requirements.

Exclusion criteria 23

1. Women who are pregnant or breastfeeding.
2. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis.
3. Past or current evidence of definite low-grade or high-grade colonic dysplasia that has not been completely removed.
4. Participants who are scheduled or anticipate the need for surgery, aside from dermatologic or other minor outpatient procedures.
5. Participants who have a known history of clinically significant drug or alcohol abuse, in the opinion of the Investigator.
6. Current symptoms of severe, progressive, or uncontrolled system disease. Concomitant medical conditions that, in the opinion of the Investigator, might place the participant at unacceptable risk for participation in this study.
7. Participants with concomitant primary sclerosing cholangitis.
8. Participants with a history of cancer within the 5 years prior to Screening (other than non-melanoma skin cell cancers cured by local resection).
9. Participants at risk for tuberculosis (TB).
10. Participants with any serious bacterial infection within 3 months prior to Screening.
11. Positive stool polymerase chain reaction (PCR) or culture for enteric pathogens.
12. Stool positive for Clostridioides difficile (C. difficile) infection.
13. Clinically significantly abnormal laboratory values.
14. Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
15. Legal or mental incapacitation, or inability to understand and comply with the requirements of the study.
16. Allergy to intervention or any of the excipients.
17. CD patients: Diagnosis of indeterminate colitis.
18. CD patients: Suspected or diagnosed intra-abdominal or perianal abscess at Screening.
19. CD patients: Current stoma or impending need for ostomy or participants with ileo-anal pouch.
20. CD patients: Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments.
21. CD patients: CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
22. UC patients: Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation.
23. UC patients: Previous total proctocolectomy or subtotal colectomy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Proportion of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values
2. Prospective Observer-Blinded Endpoint ISAs: CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase
3. Randomized Placebo-Controlled ISAs: Proportion of participants with clinical remission at end of Induction Phase

Secondary endpoints 11

1. Proportion of participants with clinical remission at end of Induction Phase
2. CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase
3. Proportion of participants with Patient-Reported Outcome-2 (PRO-2) remission at end of Induction Phase
4. Proportion of participants with clinical response at end of Induction Phase
5. CD: Proportion of participants with endoscopic and clinical response at end of Induction Phase
6. UC: Proportion of participants with histologic response at end of Induction Phase
7. UC: Proportion of participants with histologic remission at end of Induction Phase
8. UC: Proportion of participants with histologic-endoscopic mucosal improvement at end of Induction Phase
9. CD: Change in SES-CD from Day 1 to end of Induction Phase UC: Change in MES from Day 1 to end of Induction Phase
10. CD: Change in Global Histologic Activity Score (GHAS) and RHI from Day 1 to end of Induction Phase UC: Change in Geboes score, RHI, and Nancy Histological Index (NHI) from Day 1 to end of Induction Phase Descriptive summaries of PK of investigational drug
11. Descriptive summaries of PK of investigational drug

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mirador Therapeutics Inc.

Sponsor organisation

Mirador Therapeutics Inc.

Address

4902 Headquarters Point Suite 300

City

San Diego

Postcode

92121-5005

Country

United States

Scientific contact point

Organisation

Mirador Therapeutics Inc.

Contact name

Mirador Clinical Trials

Public contact point

Organisation

Mirador Therapeutics Inc.

Contact name

Mirador Clinical Trials

Third parties 3

Locations

8 EU/EEA countries · 40 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 110 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications